scholarly journals Postoperative Drainage for 6, 12, or 24 Hours After Burr-Hole Evacuation of Chronic Subdural Hematoma in Symptomatic Patients (DRAIN-TIME 2): Study Protocol for a Nationwide Randomized Controlled Trial

2021 ◽  
Author(s):  
Mads Hjortdal Grønhøj ◽  
Thorbjørn Søren Rønn Jensen ◽  
Ann Kathrine Sindby ◽  
Rares Miscov ◽  
Torben Hundsholt ◽  
...  
Keyword(s):  
Recurrence Rate ◽  
Controlled Trial ◽  
Chronic Subdural Hematoma ◽  
Burr Hole ◽  
Randomized Controlled ◽  
Drainage Time ◽  
Sf 36 ◽  
Drain Time ◽  
Postoperative Drainage ◽  
Burr Hole Evacuation

Abstract Background: Chronic subdural hematoma (CSDH) is a common acute or subacute neurosurgical condition, typically treated by burr-hole evacuation and drainage. Recurrent CSDH occurs in 5-20 % of cases and requires reoperation in symptomatic patients, sometimes repeatedly. Postoperative subdural drainage of maximal 48 hours is effective in reducing recurrent hematomas. However, the shortest possible drainage time without increasing the recurrence rate is unknown.Methods: DRAIN-TIME 2 is a Danish multi-center, randomized controlled trial of postoperative drainage time including all four neurosurgical departments in Denmark. Both incapacitated and mentally competent patients are enrolled. Patients older than 18 years, free of other intracranial pathologies or history of previous brain surgery, are recruited at time of admission or no later than 6 hours after surgery. Each patient is randomized to either 6, 12, or 24 hours of passive subdural drainage following single burr-hole evacuation of a CSDH. Mentally competent patients are asked to complete the SF-36 questionnaire. The primary endpoint is CSDH recurrence rate at 90 days. Secondary outcome measures include SF-36 at 90 days, length of hospital stay, drain-related complications, and complications related to immobilization and mortality.Discussion: This multi-center trial will provide evidence regarding shortest possible drainage time without increasing the recurrence rate. The potential impact of this study is significant as we believe that a shorter drainage period may be associated with fewer drain-related complications, faster mobilization, fewer complications related to immobilization, and shorter hospital stays—thus reducing the overall health service burden from this condition. The expected benefits for patients’ lives and health costs will increase as the CSDH patient population grows.Trial registration: ISRCTN15186366. https://doi.org/10.1186/ISRCTN15186366. Registered in December 2020 and updated in October 2021.This protocol was developed in accordance with the SPIRIT checklist and by use of the structured study protocol template provided by BMC Trials.

Randomized Controlled Trial of the Use of Drains Versus No Drains after Burr Hole Evacuation of Chronic Subdural Hematoma

Neurosurgery ◽  
2009 ◽  
Vol 65 (2) ◽  
pp. 401-401 ◽  
Author(s):  
Thomas Santarius ◽  
Peter J. Kirkpatrick ◽  
Dharmendra Ganesan ◽  
Hui Ling Chia ◽  
Ibrahim Jalloh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Subdural Hematoma ◽  
Controlled Trial ◽  
Chronic Subdural Hematoma ◽  
Burr Hole ◽  
Randomized Controlled ◽  
Burr Hole Evacuation

scholarly journals Twist drill craniostomy vs Burr hole craniostomy in chronic subdural hematoma: a randomized study

2017 ◽  
Vol 31 (3) ◽  
pp. 346-355
Author(s):  
Somil Jaiswal ◽  
A.K. Chaudhuri ◽  
S.N. Ghosh ◽  
S. Ghosh ◽  
S.K. Saha ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Randomized Study ◽  
Chronic Subdural Hematoma ◽  
Burr Hole ◽  
Twist Drill ◽  
Randomized Controlled ◽  
Subdural Hematomas ◽  
Prospective Randomized Controlled Trial ◽  
Surgical Duration

Abstract Aim: To compare two most common operative procedures used in patients with chronic subdural hematomas - Twist drill craniostomy and Burr Hole Craniostomy. Material and Methods: The study was a prospective randomized controlled trial on patients with chronic subdural hematomas. Results: Both procedures are comparable with respect to outcome but surgical duration is statistically higher in Burr Hole craniostomy than Twist Drill Craniostomy. Conclusion: Twist Drill Craniostomy is procedure of choice in emergency surgical situation.

National randomized clinical trial on subdural drainage time after chronic subdural hematoma evacuation

2021 ◽  
pp. 1-8
Keyword(s):  
Hospital Stay ◽  
Subdural Hematoma ◽  
Chronic Subdural Hematoma ◽  
Length Of Hospital Stay ◽  
Burr Hole ◽  
Drainage Time ◽  
Postoperative Length ◽  
The Mean ◽  
Burr Hole Evacuation

OBJECTIVE Placement of a subdural drain reduces recurrence and death after evacuation of chronic subdural hematoma (CSDH), but little is known about optimal drainage duration. In the present national trial, the authors investigated the effect of drainage duration on recurrence and death. METHODS In a randomized controlled trial involving all neurosurgical departments in Denmark, patients treated with single burr hole evacuation of CSDH were randomly assigned to 24 hours or 48 hours of postoperative passive subdural drainage. Follow-up duration was 90 days, and the primary study outcome was recurrent hematoma requiring reoperation. Secondary outcome was death. In addition, complications and length of hospital stay were recorded and analyzed. RESULTS Of the 420 included patients, 212 were assigned 24-hour drainage and 208 were assigned 48-hour drainage. The recurrence rate was 14% in the 24-hour group and 13% in the 48-hour group. Four patients died in the 24-hour group, and 8 patients died in the 48-hour group; this difference was not statistically significant. The ORs (95% CIs) for recurrence and mortality (48 hours vs 24 hours) were 0.94 (0.53–1.66) and 2.07 (0.64–7.85), respectively, in the intention-to-treat analysis. The ORs (95% CIs) for recurrence and mortality per 1-hour increase in drainage time were 1.0005 (0.9770–1.0244) and 1.0046 (0.9564–1.0554), respectively, in the as-treated sensitivity analysis that used the observed drainage times instead of the preassigned treatment groups. The rates of surgical and drain-related complications, postoperative infections, and thromboembolic events were not different between groups. The mean ± SD postoperative length of hospital stay was 7.4 ± 4.3 days for patients who received 24-hour drainage versus 8.4 ± 4.9 days for those who received 48-hour drainage (p = 0.14). The mean ± SD postoperative length of stay in the neurosurgical department was significantly shorter for the 24-hour group (2 ± 0.9 days vs 2.8 ± 1.6 days, p < 0.001). CONCLUSIONS No significant differences in the rates of recurrent hematoma or death during 90-day follow-up were identified between the two groups that randomly received either 24- or 48-hour passive subdural drainage after burr hole evacuation of CSDH.

scholarly journals A prospective randomized study of use of drain versus no drain after burr-hole evacuation of chronic subdural hematoma

2018 ◽  
Vol 5 (6) ◽  
pp. 2301
Author(s):  
Dhanapal Pattanam Velappan ◽  
Ponnaiyan Natesan Palaniappan ◽  
Anbarasi Pandian
Keyword(s):  
Recurrence Rate ◽  
Subdural Hematoma ◽  
Randomized Study ◽  
Chronic Subdural Hematoma ◽  
Burr Hole ◽  
Prospective Randomized Study ◽  
Recurrence Rates ◽  
Eligibility Criteria ◽  
Subdural Drain ◽  
Burr Hole Evacuation

Background: The incidence of chronic subdural hematoma is 1-2 per 100000 per year in the general population.  Inserting subdural drain might reduce the recurrence rate but is not commonly practiced. There are few prospective studies to evaluate the effect of subdural drains.Methods: A prospective randomized study to investigate the effect of subdural drains in the on-recurrence rates and clinical outcome following burr-hole drainage of chronic subdural hematoma was undertaken. During the study period, 100 patients with CSDH were assessed for eligibility. Among 100 patients fulfilling the eligibility criteria, 52 were assigned to drain inserted into the subdural space following burr hole drainage and 48 were assigned subdural drain was not inserted following burr hole drainage. The primary end point was recurrence needing re-drainage and to prevent post-operative pneumocephalus up to a period of 6 months from surgery.Results: Recurrence occurred in 1 of 100 patients with a drain, and 9 of 100 patients in without drain group the medical and surgical complications were comparable between the two study groups.Conclusions: Use of a subdural drain after burr-hole evacuation of a chronic subdural hematoma reduces the recurrence rate and is not associated with increased complications.

scholarly journals Burr-Hole Evacuation of Chronic Subdural Hematoma: Biophysically and Evidence-Based Technique Improvement

2019 ◽  
Vol 10 (01) ◽  
pp. 113-118 ◽  
Author(s):  
Martin Májovský ◽  
David Netuka ◽  
Vladimír Beneš ◽  
Pavel Kučera
Keyword(s):  
Recurrence Rate ◽  
Local Anesthesia ◽  
Subdural Hematoma ◽  
Scientific Evidence ◽  
Chronic Subdural Hematoma ◽  
Burr Hole ◽  
Evidence Based ◽  
Rural And Remote Areas ◽  
Burr Hole Evacuation ◽  
Reoperation Rates

ABSTRACTChronic subdural hematoma (CSDH) is one of the most common neurosurgical conditions. Despite ongoing efforts, recurrence and reoperation rates after surgical treatment remain high. We synthesize scientific evidence on the treatment of CSDH with biophysical principles and then propose a simple and effective surgical technique aiming to reduce the recurrence rate. Under local anesthesia, one burr hole is placed in the area above the maximum hematoma thickness. One drain is inserted into the dorsal direction to the deepest point of the hematoma cavity, and a second drain is inserted frontally into the highest point. Next, saline is gently instilled to the dorsal drain to eliminate air from the hematoma cavity through the frontal drain. Once saline has filled the frontal drain, the frontal drain is removed. The dorsal drain is left in situ for 48 h, and the pressure within the cavity may be adapted hydrostatically. We implemented evidence-based conclusions of previous studies and modified the classical burr-hole technique to reduce the recurrence rate. As a result, we developed a straightforward surgical procedure that is possible to perform under local anesthesia, suitable for everyday practice in rural and remote areas while working with limited resources. The novelty of this technique is in the purposeful reduction of postoperative pneumocephalus, a known independent factor of recurrence. Subdural air is eliminated during surgery using a two-drain system. Safety and efficacy of the technique need to be evaluated in future clinical trials.

Chronic Subdural Hematomas: To Drain or Not to Drain?

Neurosurgery ◽  
1985 ◽  
Vol 16 (2) ◽  
pp. 185-188 ◽  
Author(s):  
Thomas Marc Markwalder ◽  
Rolf W. Seiler
Keyword(s):  
Clinical Improvement ◽  
Closed System ◽  
Subdural Hematoma ◽  
Drainage System ◽  
Chronic Subdural Hematoma ◽  
Burr Hole ◽  
Postoperative Phase ◽  
Consecutive Series ◽  
Neurological Improvement ◽  
Burr Hole Evacuation

Abstract A consecutive series of 21 adult patients with chronic subdural hematoma was studied in respect to postoperative resolution of subdural collections and clinical improvement after burr hole evacuation without subdural drainage. This series was compared to a previously studied series of patients with chronic subdural hematoma in whom postoperative closed system drainage had been installed. Using the identical protocol for treatment and postoperative follow-up, we obtained identical results with respect to time-related neurological improvement and persistence of subdural collections in the undrained and drained series, except that the steadily progressive clinical improvement during the early postoperative phase (24 hours) in all cases of the drained series was not universal in the undrained cases. Our study suggests that, to avoid the possibility of early postoperative clinical deterioration, burr hole craniostomy and closed system drainage is advisable. We think that subdural drainage is not necessary when the installation of the drainage system seems to be technically difficult, as it may be in cases with considerable perioperative cortical expansion.

scholarly journals Effect of acupuncture for methadone maintenance treatment patients: study protocol of a randomized clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Hao Wen ◽  
Shichao Xu ◽  
Jingchun Zeng ◽  
Shuqi Ge ◽  
Yuan Liao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adjunctive Therapy ◽  
Opioid Dependence ◽  
Methadone Maintenance ◽  
Controlled Trial ◽  
Urine Test ◽  
Efficacy And Safety ◽  
Opioid Use ◽  
Randomized Controlled ◽  
Sf 36

Abstract Background Opioid dependence is an increasing public health problem all over the world. Patients with opioid dependence have to receive methadone maintenance therapy (MMT) as replacement therapy for years or even for their entire life. Acupuncture as a kind of therapy has been used to treat substance dependence for many years. Jin’s three-needle acupuncture (JTN), a type of acupuncture technique, has been applied to treat various diseases for several decades. However, JTN as an acupuncture technique has not been used to treat patients receiving MMT. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT. Methods/design This study is a parallel-arm, randomized controlled trial that aims to evaluate the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT. A total of 140 eligible participants who range in age from 18 to 60 years and fulfil the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), for opiate dependence will be enrolled into this study. All eligible participants will be randomly assigned to the acupuncture group or routine group in a 1:1 allocation ratio. Participants who are enrolled in the acupuncture group will receive MMT and JTN treatment for 30 min per session. Meanwhile, those who are assigned to the routine arm will receive MMT only. All 18 sessions of JTN treatment will be delivered over 6 weeks (3 per week) and followed by a 4-week follow-up period. The primary outcome measure will be the visual analogue scale (VAS) for drug craving and the daily consumption of methadone (DCOM). Secondary outcome measures will include the urine test for opioid use, the 36-item Short Form Survey (SF-36), the Beck Anxiety Inventory (BAI), the Beck Depression Inventory II (BDI-II) and Pittsburgh sleep quality index (PSQI). VAS, DCOM, BAI, BDI-II and the urine test for opioid use will be evaluated at baseline, the second week, the fourth week, the sixth week and the tenth week. SF-36 and PSQI will be assessed at baseline, the fourth week, the sixth week and the tenth week. Discussion The results of this trial will provide evidence on the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT. Trial registration Chinese Clinical Trial Registry ChiCTR1900026357. Registered on 2 October 2019.

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